Device Classification Name |
Medical Glove, Specialty
|
510(k) Number |
K982832 |
Device Name |
PROGUARD, RR-1, RR-2 |
Applicant |
EMERSON & CO. S.R.L. |
PIAZZA DELLA VITTORIA 10/12 |
GENOA,
IT
16121
|
|
Applicant Contact |
STEFANO COSTIGLTOLO |
Correspondent |
EMERSON & CO. S.R.L. |
PIAZZA DELLA VITTORIA 10/12 |
GENOA,
IT
16121
|
|
Correspondent Contact |
STEFANO COSTIGLTOLO |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/12/1998 |
Decision Date | 12/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|